Lamotrigine
NDC Package 49349-710-20

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was discontinued by the firm.

Lamotrigine is used alone or with other medications to prevent and control seizures. Marketed by Remedyrepack Inc., this product is identified by NDC 49349-710 and is authorized under FDA application ANDA076420.

Identification & Billing

NDC Package Code
49349-710-20
Package Description
100 TABLET, CHEWABLE in 1 CANISTER
Product Code
49349-710
11-Digit Billing Format
49349071020

Clinical Specifications

Proprietary Name
Lamotrigine
Dosage Form
-
Usage Information
Lamotrigine is used alone or with other medications to prevent and control seizures. It may also be used to help prevent the extreme mood swings of bipolar disorder in adults. Lamotrigine is known as an anticonvulsant or antiepileptic drug. It is thought to work by restoring the balance of certain natural substances in the brain. This drug is not approved for use in children younger than 2 years due to an increased risk of side effects (such as infections).

Regulatory & Marketing

Labeler Name
Remedyrepack Inc.
FDA Application #
ANDA076420
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
09-08-2011
End Marketing Date
04-19-2017
Listing Expiration
04-19-2017
Exclude Flag
D
Sample Package
No

Hierarchy Structure

Code Lineage

The NDC Directory contains ONLY information on final marketed drugs submitted to FDA electronically by labelers. A labeler might be a manufacturer, re-packager or re-labeler. The product information included in the NDC directory does not indicate that FDA has verified the information provided by the product labeler. Assigned NDC numbers are not in any way an indication of FDA approval of the product.

* Please review the full disclaimer at the bottom of this page.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 49349-710-20 identifies a specific commercial package of 100 tablet, chewable in 1 canister of Lamotrigine, labeled by Remedyrepack Inc.. This is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by Remedyrepack Inc. on September 08, 2011. The current certification is valid through April 19, 2017.

What are the primary indications for this medication?

Lamotrigine is used alone or with other medications to prevent and control seizures. It may also be used to help prevent the extreme mood swings of bipolar disorder in adults. Lamotrigine is known as an anticonvulsant or antiepileptic drug. It is thought to work by restoring the balance of certain natural substances in the brain. This drug is not approved for use in children younger than 2 years due to an increased risk of side effects (such as infections).

How is this Remedyrepack Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 49349071020. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.

11-Digit Code Conversion

Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:

10-Digit Format (5-3-2)
49349-710-20
11-Digit CMS (5-4-2)
49349-0710-20

Note: The zero is added to the Product segment to maintain the 5-4-2 structure.